What happened
Original notice title
American Behavioral Research Institute, LLC MARCS-CMS 705629, April 30, 2025
From the archived source record
We acknowledge that this finding was not included on the Form FDA 483 you received, and therefore your written response does not directly address this violation as discussed in this letter. These efficacy assessments included wrist actigraphy, to estimate wake/sleep time and to assess sleep variability; the Leads Sleep Evaluation Questionnaire (LSEQ), which measures sleep and daytime effects; and a daily sleep diary that rated the quality of the subjects’ sleep and the quality of the subjects’ day by rating their daily energy. The wrist actigraphy data were compared from the lead-in period (averaged as a baseline) to Days 8 to 15, with variables measured, including total sleep time and awake time. In their written response, ABRI also stated that because they are in the business of marketing and distributing dietary supplements, and not performing clinical studies, there is no risk of future violations because there is no chance of future studies. Your failure to submit, and to have in effect, an IND before initiating Protocol ABRI-002 with an investigational drug raises significant concerns about the safety and welfare of enrolled subjects, and raises concerns about the validity and integrity of the data collected during the conduct of this clinical investigation. Within 15 business days of your receipt of this letter, you should notify this office in writing of the actions you have taken to prevent similar violations in the future. Failure to address this matter adequately may lead to regulatory action. Should you have any questions or concerns regarding this letter or the inspection, please e-mail FDA at CDER-OSI-Communications@fda.hhs.gov.
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- No closeout listed in FDA table
- Source checked
- Jul 16, 2026
- Record revision
- 8b4fea56a914
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
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